Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma

Phase 1

Not yet recruiting

• Conditions: NK Cell; B-cell Lymphoma Refractory; B-cell Lymphoma Recurrent
• Interventions: Combination Product: autologous NK cell

• Registration Number: NCT05909098
• Lead Sponsor: Xiangyang No.1 People's Hospital

Brief Summary

This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.

Detailed Description

This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Study Start: 2023-07-01
• Primary Completion: 2026-12-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
2. Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.
3. First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
4. ECOG scores were 0 to 2
5. Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.
6. For women of childbearing potential, a negative pregnancy test must be confirmed before inclusion in the study and no intention to have children within 2 years.
7. For men of childbearing potential, inform and require the use of an effective barrier contraceptive method.
8. Volunteer to participate in the trial and sign the informed consent form.

Exclusion Criteria

1. Presence of bone marrow or/and central nervous system lymphoma.
2. Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.
3. Combined with other malignancies.
4. Fever of non-disease-related origin within the last 5 days.
5. Presence of uncontrollable bacterial, fungal, viral or other infections.
6. Patients with HIV, TP positive
7. Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction are present.
8. Presence of other serious diseases that conflict with this protocol, such as autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet dysfunction syndrome, etc.
9. Received any form of organ transplantation, including allogeneic stem cell transplantation.
10. Presence of a serious psychiatric disorder.
11. Inability to communicate normally and incapacitation make it difficult to assess the safety and effectiveness of treatment.
12. Pregnant or lactating women.
13. The researchers deemed unsuitable for participation in this study. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NK cell	autologous NK cell	autologous NK cell adjuvant therapy

Primary Outcome Measures

Name	Time	Method
ORR	up to 5 years of treatment	Refer to the 2014 version of Lugano standard

Secondary Outcome Measures

Name	Time	Method
PFS	up to 5 years of treatment	Refer to the 2014 version of Lugano standard
PD	up to 5 years of treatment	Refer to the 2014 version of Lugano standard
ECOG	up to 5 years of treatment	ECOG score Zubrod-ECOG-WHO (ZPS, 5-point scale)
CR	up to 5 years of treatment	Refer to the 2014 version of Lugano standard
CBR	up to 5 years of treatment	Refer to the 2014 version of Lugano standard
OS	up to 5 years of treatment	Refer to the 2014 version of Lugano standard
SD	up to 5 years of treatment	Refer to the 2014 version of Lugano standard
PR	up to 5 years of treatment	Refer to the 2014 version of Lugano standard
DOR	up to 5 years of treatment	Refer to the 2014 version of Lugano standard
EORTC QLQ-C30	up to 5 years of treatment	EORTC:The European O-rganization for Reasearch and Treatment of Cancer

Trial Locations

Locations (1)

EC of Xiangyang No.1 People's Hospital Hubei University of Medicine; 🇨🇳 Hubei, Xiangyang, China